WO2017166696A1 - Analyseur de gaz sanguin et carte de test biochimique de gaz sanguin associée - Google Patents

Analyseur de gaz sanguin et carte de test biochimique de gaz sanguin associée Download PDF

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Publication number
WO2017166696A1
WO2017166696A1 PCT/CN2016/097632 CN2016097632W WO2017166696A1 WO 2017166696 A1 WO2017166696 A1 WO 2017166696A1 CN 2016097632 W CN2016097632 W CN 2016097632W WO 2017166696 A1 WO2017166696 A1 WO 2017166696A1
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WO
WIPO (PCT)
Prior art keywords
liquid
pipe
test
test card
blood gas
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PCT/CN2016/097632
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English (en)
Chinese (zh)
Inventor
朱志华
王继华
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广州万孚生物技术股份有限公司
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Publication of WO2017166696A1 publication Critical patent/WO2017166696A1/fr

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
    • G01N27/416—Systems
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
    • G01N27/416—Systems
    • G01N27/4163—Systems checking the operation of, or calibrating, the measuring apparatus

Definitions

  • the invention relates to the technical field of medical technology, in particular to a blood gas analyzer and a blood gas biochemical test card thereof.
  • the blood gas biochemical test card is widely used in the medical industry.
  • the test card integrates the biochemical test electrode, and is calibrated by the calibration liquid in the reagent package, and then the test liquid is tested. After the test is completed, in order to prevent the calibration liquid and the test liquid from being
  • the calibrator pipe flows out, and the calibration liquid port of the test card is generally sealed by a sealing plug.
  • the syringe of the reagent bag in the instrument needs to pierce the sealing plug to communicate with the pipe in the test card. During the piercing process, the sealing plug is prone to generate debris, and the debris easily flows with the calibration solution.
  • test tube On the test electrode, the test tube is untested and the test card is scrapped; and after the test card is completed, the injection needle needs to be separated from the sealing plug, and the sealing plug has been pierced and there is a puncture and perforation, so the sealing plug cannot completely seal the piercing and perforation.
  • the test solution flows out from the piercing hole, causing a hidden danger of liquid contamination.
  • the object of the present invention is to provide a blood gas analyzer and a blood gas biochemical test card, which can avoid the problem of liquid leakage and pollution, and eliminate the hidden danger of test scrapping caused by debris contaminating the electrode.
  • a blood gas biochemical test card includes at least a test card body provided with an inlet, a calibration liquid port and a liquid pipe, a liquid pipe and an electrode circuit board disposed on the test card body, and the liquid pipe includes a connected test liquid pipe
  • the calibration liquid port is separated from the external device, and the test liquid is stored in the electrode pipe and the calibration liquid pipe. Since the liquid level of the calibration liquid pipe is higher than the liquid level of the test liquid, no external force is applied. The test solution cannot flow through the highest level of the calibrator pipe, and the liquid will not leak from the calibrator port. Prevent liquid contamination.
  • the calibration liquid port of the invention does not need to be provided with a sealing plug, and the external device directly communicates with the calibration liquid port, and there is no problem of debris generated by piercing the sealing plug, and the debris is contaminated by the electrode. Test the hidden dangers of retirement.
  • the test card body further has a suction port
  • the liquid pipeline further comprises a waste liquid cavity
  • one end of the electrode pipe away from the test liquid pipe is connected with the liquid inlet of the waste liquid cavity
  • the liquid outlet of the waste liquid cavity is connected with the suction port.
  • the liquid outlet is located above the liquid inlet.
  • the air suction port of the invention does not need to be provided with a sealing plug, and the external device directly communicates with the air suction port, and there is no problem of chipping due to piercing the sealing plug, and the hidden danger of the test scrapping caused by the debris contamination is eliminated. .
  • the waste liquid chamber comprises at least a first waste liquid chamber and a second waste liquid chamber arranged side by side, a liquid discharge port connecting the first waste liquid chamber and the second waste liquid chamber, and the bottom of the first waste liquid chamber is provided
  • the liquid inlet, the top of the second waste liquid chamber is provided with a liquid outlet, and the liquid discharge port is close to the top of the first waste liquid chamber or the second waste liquid chamber.
  • a support column is disposed in the first waste liquid chamber and the second waste liquid chamber. By setting the support column, the test film on the test card is prevented from falling into the waste liquid chamber when the test card is pumped through the suction port.
  • the liquid level of the calibrator pipe is recessed with a leak-proof groove with an opening facing upward.
  • the blood gas biochemical test card further includes an electrode test slot, and the bottom of the electrode tube is connected to the electrode circuit board through the electrode test slot.
  • the blood gas biochemical test card further includes a sealing film for the pressing member and the closed liquid pipe
  • the sealing film is an elastic composite film, and the opposite surface of the test liquid pipe and the sealing film is provided with a groove, and the sealing film is located between the groove and the pressing member, and the pressing member is provided with a pressing head matching the shape of the groove.
  • the groove is arranged in the test liquid pipe, and is integrated with the test liquid pipe, there is no excess cavity, no air bubbles remain, and the amount of the test liquid is reduced, and the test accuracy is improved; there is no need to set the on/off switch rubber plug and the test card body
  • the sealing film covering the channel switch rubber plug avoids gas leakage problems, reduces the number of parts, facilitates production, and reduces product defect rate.
  • the sealing film comprises a film, an elastic silicone film and a PET film, and the film is adhered between the test card body and the elastic silicone film, and the PET film covers the side of the elastic silicone film facing away from the groove.
  • the film acts as an adhesive sealing film and the main body of the test card, so that the tubes of the test card are closed;
  • the elastic silicone film acts as a sealing, and is filled into the groove of the test card body by the elasticity of the elastic silicone film itself;
  • the PET film supports and The resetting action ensures that the sealing film can be effectively reset after the external force is removed while the sealing film is deformed, and the sealing film adopts a flat and large-surface film sealing method to seal the liquid pipeline in the entire test card, thereby further avoiding the gas leakage problem.
  • the bottom of the groove is provided with a protrusion that protrudes toward one side of the sealing film.
  • the protrusion is embedded in the sealing film to make the sealing effect of the test liquid pipe better.
  • the invention also provides a blood gas analyzer, comprising a reagent package, a pump and a blood gas biochemical test card, wherein the reagent package is provided with a first pin connected to the calibration liquid port, and the pump is provided with a second pin connected to the air suction port.
  • the calibration liquid is extracted, and when the electrode is calibrated, the test liquid pipeline is closed, and the reagent package works to connect the calibration liquid pipeline in the reagent package with the calibration liquid inlet, the pump is connected with the suction port, and the pump works to generate a negative pressure in the liquid pipeline. Therefore, the calibrating solution flows from the reagent bag into the calibration liquid pipe and the electrode pipe of the test card; after the calibration is completed, the reagent package rotates to make the air pipe in the reagent bag communicate with the calibration liquid port, and the pump continues to work.
  • Negative pressure is generated in the liquid pipe, so that the air flows from the reagent bag into the calibration liquid pipe and the electrode pipe, and the calibration liquid is pumped into the waste liquid cavity; after that, the test liquid is extracted, the test liquid pipe is opened, and the reagent package works to make the reagent
  • the inner pipe and the calibration liquid port are closed, and the pump continues to work to generate a negative pressure in the liquid pipe, so that the test liquid flows from the inlet into the test liquid pipe and the electrode pipe, and the test liquid is tested; Blood gas biochemical test card blood gas analyzer to avoid liquid leakage and contamination Dyeing problems and eliminating the hidden dangers of test scrapping caused by debris contamination of the electrodes.
  • the blood gas analyzer further comprises a sealing member, the sealing member is sleeved on the first pin and the second pin, and the outer wall of the test card body is provided with a sealing groove matching the shape of the sealing member.
  • the blood gas analyzer is better in preventing liquid leakage.
  • the sealing member is sealed on the first pin and the second pin, respectively, and separated from the test card body to ensure the sealing, and Avoid eliminating debris from contaminating the electrode and causing hidden dangers of test rejection.
  • the present invention has the following beneficial effects:
  • the air suction port and the calibration liquid port are separated from the external device, the calibration liquid is stored in the waste liquid cavity, and the test liquid is stored in the electrode pipe and the calibration liquid pipe, because the liquid outlet of the waste liquid chamber is located Above the inlet port, under the action of no external force, the calibration solution cannot flow out from the outlet, and the suction port connected to the outlet port will not leak liquid and prevent liquid contamination; and the liquid level of the calibration liquid pipeline is the highest. The liquid level is higher than the liquid level of the test liquid. Under the action of no external force, the test liquid cannot flow through the highest liquid level of the calibration liquid pipeline, and the liquid will not leak from the calibration liquid outlet to prevent liquid contamination.
  • FIG. 1 is a schematic structural view of a blood gas biochemical test card according to an embodiment of the present invention
  • Figure 2 is a cross-sectional view taken along line A-A of Figure 1;
  • FIG. 3 is an enlarged view of I of Figure 2;
  • FIG. 4 is a schematic structural view of a blood gas analyzer according to an embodiment of the present invention.
  • FIG. 5 is a schematic view showing a first working state of a blood gas analyzer according to an embodiment of the present invention
  • FIG. 6 is a schematic view showing a second working state of a blood gas analyzer according to an embodiment of the present invention.
  • Fig. 7 is a schematic view showing the third working state of the blood gas analyzer according to the embodiment of the present invention.
  • Test card body 110. Inlet, 120. Pumping port, 130. Liquid pipe, 131. Test liquid pipe, 1311. Groove, 1312. Protrusion, 132. Calibration liquid pipe, 1321. Calibration liquid Mouth, 1322. Leakproof groove, 1323. Top, 133. Waste chamber, 1331. Inlet, 1332. Outlet, 1333. Drain, 1334. First waste chamber, 1335. Second waste chamber, 134. Electrode tubing, 135 Waste liquid pipeline, 140. Support column, 150. Electrode test tank, 160. Seal, 170. Sealing groove, 20. Electrode circuit board, 40. Pressing piece, 410. Indenter, 50. Sealing film, 510. Film, 520. elastic silicone film, 530. PET film, 60. syringe, 70. syringe, 80. reagent pack, 810. first pin, 90. pump, 910. second pin.
  • a blood gas biochemical test card includes at least a test card body 10 provided with an inlet 110, a calibrated liquid port 1321 and a suction port 120, and a liquid pipe disposed on the test card body 10.
  • the liquid pipe 130 includes a test liquid pipe 131, a calibrating liquid pipe 132, a waste liquid chamber 133, and an electrode pipe 134 connected to the electrode circuit board 20, the test liquid
  • One end of the pipe 131 communicates with the inlet 110, the other end communicates with the calibration liquid pipe 132 and the electrode pipe 134, and one end of the calibration liquid pipe 132 away from the test liquid pipe 131 communicates with the calibration liquid port 1321, and the electrode pipe 134 is far away from the test.
  • One end of the liquid pipe 131 communicates with the liquid inlet 1331 of the waste liquid chamber 133, the liquid outlet 1332 of the waste liquid chamber 133 communicates with the suction port 120, and the liquid outlet 1332 is located above the liquid inlet 1331, and the calibration liquid pipe 132 The highest level is above the level of the test solution.
  • the air suction port 120 and the calibration liquid port 1321 are separated from the external device, the calibration liquid is stored in the waste liquid chamber 133, and the test liquid is stored in the electrode pipe 134 and the calibration liquid pipe 132, due to the waste liquid chamber 133
  • the liquid outlet 1332 is located above the liquid inlet 1331, and the calibration liquid cannot flow out from the liquid outlet 1332 without external force, so that the liquid outlet 120 communicating with the liquid outlet 1332 does not leak liquid and prevent liquid contamination;
  • the highest liquid level of the calibration liquid pipe 132 that is, the top portion 1323 of the pipe is higher than the liquid surface of the test liquid, and the test liquid cannot flow through the highest liquid level of the calibration liquid pipe 132 without external force, and the liquid does not pass from the liquid level of the calibration liquid pipe 132.
  • the calibration liquid port 1321 leaks to prevent liquid contamination. Compared with the conventional test card, there is no need to provide a sealing plug on the calibration liquid port 1321 and the suction port 120 of the present invention, and the external device directly communicates with the calibration liquid port 1321 and the suction port 120, and there is no piercing of the sealing plug. The problem of chipping is eliminated, and the hidden contamination of the electrode caused by the debris is eliminated.
  • the waste liquid chamber 133 includes a first waste liquid chamber 1334 and a second waste liquid chamber 1335 arranged side by side, a liquid discharge port 1333 connecting the first waste liquid chamber 1334 and the second waste liquid chamber 1335, first
  • the bottom of the waste liquid chamber 1334 is provided with a liquid inlet 1331
  • the top of the second waste liquid chamber 1335 is provided with a liquid outlet 1332 which is located on the side close to the liquid outlet 1332.
  • the calibrator is stored in the first waste liquid chamber 1334, a liquid discharge port 1333 is disposed between the first waste liquid chamber 1334 and the second waste liquid chamber 1335, and the liquid discharge port 1333 is located near the liquid discharge port 1332.
  • the liquid chamber 1334 flows into the second waste liquid chamber 1335 to further prevent liquid from leaking out of the suction port 120.
  • the waste liquid chamber 133 can also be set to more than one according to actual needs.
  • the liquid pipe 130 further includes a waste liquid pipe 135, and a waste liquid pipe 135 is connected between the liquid discharge port 1332 and the air suction port 120.
  • the top portion 1323 of the calibrating fluid conduit 132 is recessed with a leak-proof groove 1322 with an opening facing upward.
  • the leakage preventing groove 1322 can also be disposed between the top portion 1323 of the calibrating liquid pipe 132 and the end of the calibrating liquid pipe 132 connected to the test liquid pipe 131 according to actual needs.
  • the blood gas biochemical test card further includes an electrode test slot 150, and the bottom of the electrode duct 134 is connected to the electrode circuit board 20 through the electrode test slot 150.
  • the blood gas biochemical test card further includes a pressing member 40.
  • the sealing film 50 is an elastic composite film, and the opposite surface of the testing liquid pipe 131 and the sealing film 50 is provided with a groove 1311, and the sealing film 50 is located in the concave shape. Between the groove 1311 and the abutting member 40, the pressing member 40 is provided with a ram 410 that is shaped to match the groove 1311.
  • the test liquid pipe 131 is closed; when the pressing member 40 leaves the sealing film 50, the sealing film 50 is elastically deformed away from the groove 1311 by itself.
  • the test liquid pipe 131 is opened.
  • the groove 1311 is disposed in the test liquid pipe 131, and is integrated with the test liquid pipe 131. There is no excess cavity, no air bubbles remain, and the amount of the test liquid is reduced, and the test accuracy is improved; the switch card body 10 does not need to be provided with an on/off switch. Rubber plug and sealing film for covering the channel switch rubber plug, avoiding air leakage problems, reducing the number of parts, facilitating production and reducing production Product defect rate.
  • the sealing film 50 includes a film 510, an elastic silicone film 520, and a PET film 530.
  • the film 510 is adhered between the test card body 10 and the elastic silicone film 520.
  • the film 530 covers the side of the elastic silicone film 520 facing away from the groove 1311.
  • the adhesive film 510 functions as the adhesive sealing film 50 and the test card main body 10, so that the test card pipes are closed; the elastic silicone film 520 acts as a sealing, and is filled into the groove 1311 by the elasticity of the elastic silicone film 520 itself; the PET film 530
  • the support film and the resetting function ensure that the sealing film 50 is deformed while ensuring effective sealing of the sealing film 50 after the external force is eliminated, and the sealing film 50 seals the liquid pipe 130 in the entire test card by a flat and large-surface filming method, further avoiding Air leak problem.
  • the sealing film 50 can also adopt other structural forms according to actual needs.
  • the bottom of the groove 1311 is provided with a projection 1312 which is convex toward the side of the sealing film, and the projection has a rib shape.
  • the projection 1312 is fitted into the sealing film 50 to make the sealing effect of the test liquid pipe 131 better.
  • two support columns 140 are disposed in the first waste liquid chamber 1334 and the second waste liquid chamber 1335.
  • the test film 50 is prevented from being trapped in the waste liquid chamber 133 when the test card is evacuated through the suction port 120.
  • the first waste liquid chamber 1334 and the second waste liquid chamber 1335 can also be provided with more than one support column 140 according to actual needs.
  • the blood gas biochemical test card further includes a syringe 60 that is fixed to the inlet 110 of the test card body 10 and communicates with the syringe 70, and the test solution is stored in the syringe 70.
  • the present invention further provides a blood gas analyzer comprising a reagent package 80, a pump 90 and a blood gas biochemical test card.
  • the reagent package 80 is provided with a first pin 810 communicating with the calibration liquid port 1321, and the pump 90
  • a second pin 910 is provided in communication with the suction port 120.
  • the test liquid pipe 131 is closed, and the reagent bag 80 is operated to connect the calibration liquid pipe 132 in the reagent package 80 with the calibration liquid port 1321, and the pump 90 and the suction port. 120 is connected, the pump 90 works to generate a negative pressure in the liquid pipe 130, so that the calibrating liquid flows from the reagent bag 80 into the calibration liquid pipe 132 and the electrode pipe 134 of the test card; as shown in FIG. 6, the calibration is completed.
  • the reagent pack 80 operates to allow the air conduit in the reagent pack 80 to communicate with the calibrated fluid port 1321, and the pump 90 continues to operate to create a negative pressure within the liquid conduit 130, thereby allowing air to flow from the reagent pack 80 to the reagent pack 80.
  • the calibration liquid pipe 132 and the electrode pipe 134 the calibration liquid is pumped into the first waste liquid chamber 1334; after that, the test liquid is extracted, as shown in FIG. 7, the test liquid pipe 131 is opened, and the reagent package 80 is operated to make the reagent package 80.
  • the inner pipe and the calibration liquid port 1321 are closed, and the pump 90 continues to operate to generate a negative pressure in the liquid pipe 130, so that the test liquid flows from the inlet 110 into the test liquid pipe 131 and the electrode pipe 134 to test the test liquid;
  • the blood gas analyzer with the blood gas biochemical test card can avoid liquid leakage and contamination problems, and eliminate the hidden dangers of test scrapping caused by debris contaminated electrodes.
  • the blood gas analyzer further includes a sealing member 160.
  • the sealing member 160 is sleeved on the first pin 810 and the second pin 910, and the outer wall of the test card body 10 is provided with the shape of the sealing member 160. Matching seal groove 170. The effect of preventing blood leakage of the blood gas analyzer is better.
  • the sealing member 160 of the present invention is sealed on the first pin 810 and the second pin 910, respectively, and separated from the test card body 10. Under the premise of ensuring the seal, it also avoids the hidden dangers of test scrapping caused by debris contamination of the electrode.
  • the needle positions of the first pin 810 and the second pin 910 do not need to pierce the sealing plug, but communicate with the calibration liquid port 1321 and the air suction port 120 respectively, the needle position can be set to be pointed or Set to other shapes such as flat head.
  • first pin 810 and the second pin 910 are sealed by the same sealing member 160, and the blood gas analyzer can also be sleeved on the first pin 810 and the second pin 910 according to actual needs.
  • a sealing member, the outer wall of the test card body 10 is provided with a sealing groove corresponding to the sealing member.
  • the blood gas analyzer further includes a driving device (not shown) that drives the ram 410 to reciprocate toward the side of the recess 1311.
  • the movement of the pressing member 40 is driven by the driving device to make the operation of the blood gas analyzer simpler.
  • the driving device is a motor and the pump 90 is a vacuum pump.
  • the drive unit and pump 90 can also be configured in other forms as needed.

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Abstract

L'invention concerne un analyseur de gaz sanguin et une carte de test biochimique de gaz sanguin associée, comprenant au moins : un corps de carte de test (10) pourvu d'un orifice d'entrée d'échantillon (110) et d'un orifice d'aspiration de gaz (120) ; et un tuyau de liquide (130) et une carte de circuits d'électrode (20) disposée sur le corps de carte de test (10). Le tuyau de liquide (130) comprend un tuyau de liquide de test (131), un tuyau de solution d'étalonnage (132), une chambre à déchets (133), et un tuyau d'électrode (134) connecté à la carte de circuits d'électrode (20), qui sont en communication les uns avec les autres. Une extrémité du tuyau de liquide de test (131) est en communication avec l'orifice d'entrée d'échantillon (110). Une extrémité du tuyau de solution d'étalonnage (132) comporte un orifice de solution d'étalonnage (1321), et le niveau de liquide le plus élevé (1322) du tuyau de solution d'étalonnage (132) est supérieur au niveau de liquide du liquide de test. Il n'est pas nécessaire de prévoir un bouchon de fermeture sur l'orifice de solution d'étalonnage (1321), et un dispositif externe est en communication directe avec l'orifice de solution d'étalonnage (1321). Le problème des débris qui sont générés en raison de la perforation du bouchon de fermeture n'est pas présent, et le danger caché d'échec d'un test dû à une électrode qui est contaminée par des débris est éliminé.
PCT/CN2016/097632 2016-03-31 2016-08-31 Analyseur de gaz sanguin et carte de test biochimique de gaz sanguin associée WO2017166696A1 (fr)

Applications Claiming Priority (2)

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CN201610207535.5 2016-03-31
CN201610207535.5A CN106483180A (zh) 2016-03-31 2016-03-31 血气分析仪及其血气生化测试卡

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WO2017166696A1 true WO2017166696A1 (fr) 2017-10-05

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